Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

Recruiting

Phase 4 Results N/A

Trial Description

This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute stroke patients with severe motor involvement. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke. Secondary objectives are to evaluate the safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with severe motor involvement randomized to administration of Cerebrolysin combined with rehabilitation for 3 weeks show better outcome on global function (Korean version Modified Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS), cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.

Detailed Description

Randomized double-blinded, placebo-controlled multicenter study with two treatment groups
Number of Patients: 80 patients (n = 40 per group) 5 study centers will participate in this study.
Group 1(Cerebrolysin): cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
Group 2(Placebo): saline 100 ml/day * 21 days with rehabilitation

Conditions

Interventions

  • Cerebrolysin Drug
    Other Names: Ever Pharma, Unterach am Attersee, Austria
    Intervention Desc: Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
    ARM 1: Kind: Experimental
    Label: Cerebrolysin
    Description: Cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10) Rehabilitation 3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day 5 times/week for 3 weeks Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.
  • Placebo Drug
    Intervention Desc: Placebo- saline 100 ml/day * 21 days with rehabilitation
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Saline 100 ml/day * 21 days with rehabilitation Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10) Rehabilitation 3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day 5 times/week for 3 weeks Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Score of Fugl-Meyer assessment (FMA) 3 months after stroke No
Secondary Score of Korean version Modified Barthel Index (K-MBI) 3 months after stroke No
Secondary Score of National Institute of Health Stroke Scale (NIHSS) 3 months after stroke No
Secondary Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA) 3 months after stroke No
Secondary Score of Action Research Arm Test (ARAT) and box and block test 3 months after stroke No
Secondary Score of EuroQol (EQ-5D) 3 months after stroke No
Secondary Days of Length of hospital stay 3 months after stroke No
Secondary Brain activation of resting-state functional MRI 3 months after stroke No

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